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FDA Warning Letters, 483s and Recalls: June 2019

FDA enforcement records dated June 2019: 0 warning letters outside tobacco, 45 OAI inspections and 44 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

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Warning letters

A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.

No warning letters outside tobacco are recorded for this month yet.

OAI inspections

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.

DateFacilityProduct typeCountry
Jun 28, 2019Cedar Bear Naturales Inc.Food/CosmeticsUnited States
Jun 28, 2019Christopher J. Hartnick, MDDevicesUnited States
Jun 28, 2019Dinamix Distribution, LLC.Food/CosmeticsUnited States
Jun 28, 2019Fishmarket IncFood/CosmeticsUnited States
Jun 28, 2019GPT Pharmaceuticals Private LtdDrugsIndia
Jun 28, 2019Premier Trends LLCDrugsUnited States
Jun 28, 2019Sunstar Guangzhou Ltd.DrugsChina
Jun 27, 2019Perdue AgriBusiness, LLC.VeterinaryUnited States
Jun 26, 2019Family Fertility CenterBiologicsUnited States
Jun 25, 2019EE HUI FOOD MANUFACTURE PTE LTDFood/CosmeticsSingapore
Jun 24, 2019Blue Moose Of Boulder, LLCFood/CosmeticsUnited States
Jun 24, 2019Sugarcreek Livestock Auction, Inc.VeterinaryUnited States
Jun 21, 2019Evertogen Life Sciences Ltd.DrugsIndia
Jun 21, 2019Fagron Compounding ServicesDrugsUnited States
Jun 21, 2019Luoma Egg Ranch, Inc.Food/CosmeticsUnited States
Jun 20, 2019C K Solutions, Inc.Food/CosmeticsUnited States
Jun 20, 2019Hybrid Pharma LLCDrugsUnited States
Jun 20, 2019Valley Processing IncFood/CosmeticsUnited States
Jun 20, 2019Vevazz LLCDevicesUnited States
Jun 19, 2019Signature Formulations, LLCDrugsUnited States
Jun 17, 2019Maitland Labs Of Central FloridaDrugsUnited States
Jun 17, 2019RNV LLCDrugsUnited States
Jun 14, 2019First Royal Care Co. LLCDrugsUnited States
Jun 14, 2019K-Pra Foods Private LimitedFood/CosmeticsIndia
Jun 14, 2019Ningbo BST Clean And Care Products Co., LtdDrugsChina
Jun 13, 2019Pollman's Bake Shops, Inc.Food/CosmeticsUnited States
Jun 12, 2019Peggy Lawton Kitchens, Inc.Food/CosmeticsUnited States
Jun 12, 2019Premier Pharmacy Labs IncDrugsUnited States
Jun 11, 2019Cargill IncorporatedVeterinaryUnited States
Jun 10, 2019ALTERNATIVE LABORATORIES, LLCFood/CosmeticsUnited States
Jun 10, 2019Cross Brands Contract Filling, LLCDrugsUnited States
Jun 7, 2019Tugusto Foods, Inc.Food/CosmeticsUnited States
Jun 6, 2019Adamba Imports International Inc.Food/CosmeticsUnited States
Jun 6, 2019New Mexico Food Distributors, IncorporatedFood/CosmeticsUnited States
Jun 6, 2019TAKA USA, INC.DrugsUnited States
Jun 6, 2019Xinxiang Tuoxin Pharmaceutical Co. LtdDrugsChina
Jun 5, 2019Matrix Pharmacorp Private LimitedDrugsIndia
Jun 5, 2019Shenzhen Jamr Medical Technology Co., LtdDevicesChina
Jun 5, 2019Vireo Resources, LLCFood/CosmeticsUnited States
Jun 4, 2019Balik, A Branch Of Caviar House & Prunier (Suisse) SAFood/CosmeticsSwitzerland
Jun 4, 2019Herman's NutHouse, LLCFood/CosmeticsUnited States
Jun 4, 2019MIYAQUIL SAFood/CosmeticsEcuador
Jun 4, 2019Sassy Cow Creamery, LLCFood/CosmeticsUnited States
Jun 3, 2019Health Pharma USA LLCDrugsUnited States
Jun 3, 2019Herbal Science International, Inc.Food/CosmeticsUnited States

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

CFR sectionObservationCitations
21 CFR 1.502(a)Maintain, follow FSVP37
21 CFR 117.35(a)Sanitary operations - Plant sanitation32
21 CFR 820.198(a)Lack of or inadequate complaint procedures27
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard26
21 CFR 820.100(a)Lack of or inadequate procedures26
21 CFR 117.35(c)Pest control23
21 CFR 123.11(b)Sanitation monitoring documentation22
21 CFR 117.145(a)Sanitation Controls Monitoring Proced: Establish Implement21
21 CFR 117.10Personnel20
21 CFR 123.6(b)No HACCP plan20

Class I recalls

Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.

DateFirmProduct typeReason
Jun 28, 2019Fresenius Kabi USA, LLCDrugsPresence of Particulate Matter; glass particulates
Jun 28, 2019Pure Ground IngredientsFoodProduct tested and found to be positive for Salmonella
Jun 28, 2019Pure Ground IngredientsFoodProduct tested and found to be positive for Salmonella
Jun 26, 2019Weaver Popcorn Co.FoodProduct recalled due to a concern of possible Salmonella contamination.
Jun 24, 2019Commercial Creamery Company Of Idaho, Inc.FoodWhite Cheddar Blend is recalled due to a potential contamination with Salmonella.
Jun 24, 2019Fenwal IncDevicesThe firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of…
Jun 24, 2019Fenwal IncDevicesThe firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of…
Jun 20, 2019St Jude Medical Inc.DevicesElectrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire…
Jun 20, 2019St Jude Medical Inc.DevicesElectrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire…
Jun 20, 2019St Jude Medical Inc.DevicesElectrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire…
Jun 20, 2019St Jude Medical Inc.DevicesElectrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire…
Jun 20, 2019St Jude Medical Inc.DevicesElectrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire…
Jun 20, 2019St Jude Medical Inc.DevicesElectrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire…
Jun 18, 2019Nature's Touch Frozen Foods (West)FoodWashington State Department of Agriculture sampled and tested frozen avocado and found Listeria monocytogenes.
Jun 17, 2019Brand Castle LLCFoodFirm's supplier notified them of potential E.coli contamination in flour they received.
Jun 17, 2019Brand Castle LLCFoodFirm's supplier notified them of potential E.coli contamination in flour they received.
Jun 17, 2019Brand Castle LLCFoodFirm's supplier notified them of potential E.coli contamination in flour they received.
Jun 17, 2019Brand Castle LLCFoodFirm's supplier notified them of potential E.coli contamination in flour they received.
Jun 17, 2019Brand Castle LLCFoodFirm's supplier notified them of potential E.coli contamination in flour they received.
Jun 17, 2019Brand Castle LLCFoodFirm's supplier notified them of potential E.coli contamination in flour they received.
Jun 17, 2019Datascope Corp.DevicesIf battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised…
Jun 17, 2019Datascope Corp.DevicesIf battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised…
Jun 17, 2019Datascope Corp.DevicesIf battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised…
Jun 17, 2019Datascope Corp.DevicesIf battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Jun 17, 2019Datascope Corp.DevicesBattery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed…
Jun 17, 2019Datascope Corp.DevicesIf battery maintenance is not performed per instructions, the battery may provide less than the minimum run time of operating power.
Jun 16, 2019Mai Cuisine LLCFoodProduct is recalled due to undeclared egg.
Jun 16, 2019Mai Cuisine LLCFoodProduct is recalled due to undeclared egg.
Jun 14, 2019Frito-Lay, Inc.FoodUndeclared milk
Jun 14, 2019TELEFLEX-MORRISVILLEDevicesDevice vented gas below the stated pressure.
Jun 7, 2019Bobbie Baby IncFoodThe product does not provide adequate nutrition for some infants.
Jun 7, 2019Centurion Medical Products CorporationDevicesCenturion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan…
Jun 7, 2019DILIP CERAMICS DBA SHIVAM DISTRIBUTFoodProduct contains high levels of sulfites
Jun 7, 2019PharMEDium Services, LLCDrugsIncorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the…
Jun 7, 2019The Kroger CoFoodPossible Hepatitis A contamination.
Jun 7, 2019The Kroger CoFoodPossible Hepatitis A contamination.
Jun 7, 2019The Kroger CoFoodPossible Hepatitis A contamination.
Jun 7, 2019Townsend Farms IncFoodKirkland Signature Three Berry Blend product is recalled due to potential contamination with Hepatitis A virus.
Jun 5, 2019Baumer Foods IncFoodUndeclared allergen. Worcestershire sauce mislabeled as soy sauce.
Jun 5, 2019Qiagen Sciences LLCDevicesKit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF…
Jun 5, 2019Whole Foods MarketFoodProduct labels failed to declare the major food allergens milk, walnuts, and pine nuts
Jun 5, 2019Whole Foods MarketFoodProduct labels failed to declare the major food allergens milk, walnuts, and pine nuts
Jun 4, 2019The Fresh Group, Ltd.FoodJalapeno peppers may be contaminated with Salmonella.
Jun 3, 2019Shelton Farms Dba Shelton's Wholesale CoFoodSalmonella

Check one company

See one company's full record with the free FDA compliance check, or search warning letters and Form 483 citations by name.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.